Identity
- Trade Name
- Somatom Spirit (SSME) FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Model / Reference
- 10045692 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869010274 FDA UDI
- 510(k) Number
- K042328 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Full-body CT system
Somatom Spirit (SSME) by Siemens Shanghai Medical Equipment Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042328 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Shanghai Medical Equipment Ltd.
Sources (1)
- FDA UDI 16ad3c41-1a1f-4b91-835f-8012ed480d2e 35 fields · synced Jun 8, 2026